Medical supplies otolaryngology Eustachian Tube Balloon Dilation Cathether for Eustachian Tube Dysfunction Tuboplasty

Eustachian tube balloon catheter is a passive disposable medical device. Stenosis or blockage of passage is a serious manifestation of eustachian tube mechanical dysfunction, which may cause many diseases. The device is equipped with a a inflatable balloon at the distal end. The balloon catheter reaches the eustachian tube from the nose or mouth through the nasal guiding device in different angles by pushing the rod. While the other end of the catheter is connected to the pump/injector that could inflate the balloon by performing the filling, so as to achieve the mechanical dilation of the eustachian tube.

Parts

Work theory

Models

Advantage

Safety.

No major defects reported

Effectiveness.

90% of the the users show distinguish improvement in the test report in 12 months.

Convenience.

Easy operation

Established on Feb 18th 2014, later among the first group of hi-tech enterprises in 2017, Guangdong Kangerle Medical Equipment Co.,Ltd (Kangerle Medical) set its production base in Pengjiang District, Jiangmen and operation center in Baiyun District, Guangzhou.  

Owning its independent intellectual property, Kangerle is a hi-tech enterprise specialized in high-value medical consumables and integrating with the R&D, production and sales of medical equipment.   

Kangerle Medical passed the audit of Guangdong Food and Drug Administration, and obtained the production license for medical devices (Certificate no.20142584 issued by Guangdong Food and Drug Administration on the approval of the medical equipment production); later passed the audit by TUV sud, and obtained the certificate of Quality System ISO13485-2016, CE MDD product certificates of Sinus Balloon Dilation System, Cervical Ripening Balloon Catheter and Vacuum Wound Drainage Kit.   

So far the products of Kangerle Medical range from the section of ENT, Obstetrics, Cardiology, to general surgery, including such following registered devices as Eustachian tube balloon dilatation catheter, Sinus balloon dilatation system, disposable gastric tube, disposable cervical ripening balloon catheter, disposable vacuum wound drainage kit, disposable Balloon uterine stent, and disposable endometrial sampler. GMP compliant production base is equipped with the Class 10k clean room, Class 10k(partial Class 100) sterile test room, bacteria lab, positive control lab and state-approval EO sterile equipment, and professional medical device production and test instruments.       

Kangerle Medical’s quality management system complys with ISO13485 and GMP which puts the production procedure in effective control and ensures the finished products meet the registered standards.   

Equipped with high quality production lines, advanced production and test instruments, and professional R&D and QC team, Kangerle medical is able to provide every medical institutes with high quality products and high efficiency service.  

Kangerle Medical holds the management and business principle of Manage with care, manufacture with minds, service with heart, devotes to the research, production and sales of hi-tech medical equipment, and provides the market with the most cost-effective medical equipment.

Company Development

2014: Establishment

2015: Register of Sinus Balloon Dilation System

2016: Approval of Medical Device Production. Register of Disposable Gastric Tube and Disposable Cervical Ripening Balloon Catheter

2017:Register of Disposable Vacuum Would Drain Kit

2018: Register of Guide Needle. Register of Category II Medical Equipment Business License.

2019: Register renewal and adding models of Sinus Balloon Dilation System. Register of Nasal Irrigator and Nasal Guide Kit.  

2020: Register of Eustachian Tube Balloon Dilation Catheter. Certificate ISO13485-2016 issued by  TUV sud. CE MDD certificate of Sinus Balloon Dilation System, Cervical Ripening Balloon Catheter, and Vacuum Wound Drainage Kit.